The whole idea of opiates for chronic pain is being revised, however in the aftermath of the fungal
meningitis epidemic resulting from contaminated corticosteroid injections, alternative treatments for
chronic pain are essential.
If the widespread use of corticosteroid epidural and joint injections is in response to actions to reduce
and restrict the use of opioids for chronic pain, they they may need to reconsider.
Although opioids certainly have drawbacks, such as addiction, diversion, even death from overuse,
alternative invasive treatments such as corticosteroid injections certainly have been seen to have serious
risks and their use will probably be less enthusiastic now.
Medicines such as nonsteroidal antiinflammatory meds also have dangers such as renal failure and
gastric irritation, and even hemorrhage and death from bleeding ulcers, so there is not any totally safe
and effective treatment for chronic pain presently..

Steven A. King, M.D.

12/09/12

As I noted in
earlier posting on
this drug, it really
makes no sense to
approve an extended
release form of the
drug before a
short-acting form is
available as one
would generally
start with the
latter before
proceeding to the
former..

Theodore Shively

12/09/12

The writing appears to be on the wall for drug makers. Unless a medication with the potential for abuse has deterrents to its misuse incorporated in its packaging, the potential for abuse will finally outweigh any clinical benefit that it might have. It will have a difficult time getting approved by the FDA.
REMS is too little too late. I hope they extend this same logic to all of the potentially addicting medications on the market.
It is possible for a drug manufacturer to incorporate mechanisms that would make it very difficult to abuse their product. We need a national standard that makes such deterrents not only desirable but mandatory.
At least the FDA seems to have finally gotten the message that the avalanche of deaths from narcotic overdose deserves their full attention..

Larry J. Frieders, R.Ph.

12/10/12

Hooray for the FDA? NOT!
Our drug regulators have decided it is better to give hydrocodone in
combination with acetaminophen than to offer it as a single entity.
Data demonstrates that the pure hydrocodone is safe and effective -
BUT - the regulators fear the potential for overuse and abuse. Their
fearfulness fails to recognize that chronic use of acetaminophen can
be extremely toxic (live damage, for example) - and it is even more
harmful to someone who is seriously ill AND in pain. Thankfully,
pure hydrocodone is still available, but a doctor will have to
search out one of those "unregulated" (tongue-in-cheek) compounding
pharmacies to get it for a patient in need.
This is - at best - a POOR DECISION..

Hitchfan

12/10/12

The presence of acetaminophen or ibuprofen does not prevent
overuse or overdosing --- it just makes it more likely that one
will be poisoned by the additives as well as the hydrocodone!.

kathleen jones

12/10/12

It's about tolerance, not abuse. What worked well last year doesn't work so well this year. The extended release
medicines are outrageously expensive due to the special coatings to prevent abusers from "inhaling" or
injecting
these meds. Chronic pain in a word , sucks. The constant worry over being able to tolerate the pain and work/
function is terrible as well. I didn't ever get arrested or treated for drug abuse. So, why am I treated as a potential
criminal? Invent a drug that works, and then somehow the public finds out how to abuse it, a small percentage who
access to shady doctors, who should be arrested. Chronic pain patients are treated poorly by some doctors and
many pharmacy employees, and now a &quot; board of people who decided &quot;this drug will be abused. I
worked in a
pediatric emergency room as a nurse, the most abused drug was.......overdose on Tylenol, because the boyfriend
broke up with the girl. Wow, let's not sell Tylenol to anyone under twenty one! Except they have children who may
need. It. I am miserable some days because of the pain. When I got shingles, I was told to take extra strength
Tylenol and my regular pain meds. It was horrible, I have RA and a very physical job, no husband and
"special"
adults to support. Tell me how to do this pharmacists..

djblass

12/11/12

Prior to making this comment I took the time to read
the eight posted comments that were interesting, well
written and well thought out. What was interesting to
me was the statistical breakdown in pro/nay opinions
on this new medication. Even with this small sample it
is about 50-50. With MD providers opposed and chronic
pain patients for.
I may have a unique contribution because I am a health
care professional on a total work related disability
pension who was diagnosed with chronic Stage IV pain
by an experienced neurologist. I had never heard this
term used before and it is reserved for unfortunate
patients with what is called "end stage"
pain. Most of
these people have terminal cancer or are elderly with
a diagnosis of six months or less to live. I was
injured at around age 55 and prior to that had been
extremely active and maintained an athletic level of
fitness by cross training at the gym with a very low
BMI and long life expectancy runs in both sides of my
family.
I have severe injuries to my spine. I have four
protruding discs in my lumbar spine and had three
severe discs in my cervical spine. The Work Comp
carrier procrastinated and denied surgical
intervention for so long on my neck that I now have
cord intrusion and myelopathy. I had a c-6/c-7 fusion
and laminectomy done almost two years ago by a
neurosurgeon who refused to follow the recommendation
of a more experienced colleague who recommended a two
level fusion to include c-5/c-6. The neurosurgeon did
not get informed consent for the procedure he did do
that involved a faulty medical device, and I have been
in excruciating pain for the past 18 months waiting
while the MDs and lawyers fight about the cost of the
surgical revision. Some days I wonder what kind of
karma put me in a position to deserve this?
Not only am I a genetic non-responder to acetaminophen,
it is known to be hepatotoxic. Despite all of this
against my wishes I am often forced to take pain
relief compounds with this noxious drug in them. As
far as I am concerned it is Tylenol or acetaminophen
that should be taken off the market as a pain drug. It
has probably killed and harmed as many people as some
opioid preparations. Medical professionals (especially
those who have worked in the ER know that it is fatal
in low doses and have seen suicide
"gestures" on OD's
of Tylenol from the bathroom medicine cabinet turn
into completed suicides for the lack of an antidote.
Years ago there was talk of pulling Tylenol from the
market. I may easily live another 25 years if the
surgeons don't kill me with Stage IV (terminal pain).
Am I to be denied relief without having to go to the ED
for a morphine and dilaudid drip, which I hate? All my
veins are now ruined like a junkie. Why are chronic
pain patients and the MD's who treat them
criminalized. We live in a very sick society..

djblass

12/11/12

I do not understand Dr. Steven King's comment about a
short acting version of a drug -- with psychoactive
and potentially addictive properties -- being
initially released as a safer alternative to a longer
acting version? Perhaps he can expand on his line of
thinking or maybe he was just making an attempt at
sarcastic humor? If he is treating patients in a
clinical setting I certainly hope that he is just
being sarcastic. It is quite well known that the more
short acting a psychoactive substance is, the higher
the potential for addiction. Crack cocaine is a
perfect example of this principle in that it lasts
minutes so is even more addictive than powdered
cocaine. The same is true with prescription drugs with
the longer acting formulations always being less
addictive and less attractive to addicts than the
shorter acting drugs with their immediate rush..

Bart Fargo

12/12/12

It seems the FDA
won't be happy until
all the prescription
drug addicts in
America either
switch over to
street drugs or drop
dead from the toxic
"anti-abuse"
additives to their
medications.
Whatever it takes to
keep the focus of
the drug war on
prohibition,
enforcement and
prisons while
avoiding commitment
to treatment of
addicts and the
psychosocial
conditions that
provoke addiction..

thixotropic

12/12/12

As a health
professional who
must also deal with
chronic pain, I have
long desired
time-release
hydrocodone as it
does not suppress my
appetite, unlike
oxycodone/oxymorphone.
(Morphine is
ineffective and too
sedating).
I can see no
justification for
denial based on the
current lack of an
abuse deterrent
formulation: if
memory serves,
oxymorphone generic
is also not an
abuse-deterrent
formulation.
The use of
acetaminophen/NSAID
in hydrocodone
formulations has
been a bane for pain
patients, nor does
it deter abuse. A
hydrocodone-only
medication available
in time-release
format would be a
boon to many who
find other opioids
less desirable for
whatever reason. The
vast majority of PM
patients take their
mediation exactly as
directed, and the
FDA's stance here
seems much more
politically
expedient than it
does medically
sound..

djblass

10/25/13

Anyone giving serious thought to this scheme should catch the film
'Never Let Me Go' or read the novel of the same name by a Booker Prize
winning British novelist. The ethical questions are enormous. There
are stories about poor people in India waking up on the sidewalk with
surgical scars after being kidnapped and having a kidney removed. The
South China Post when I was in Hong Kong was running front page
stories of criminals being executed to coincide with the need for
organ donations. It might be fine to be on the receiving end of such
an anatomical 'gift' but I would not like to be the giver..

djblass

12/23/13

The 'so-called' war on drugs is a self-acknowledged failure. It has
been costly in tax dollars; increased the homicide rate in the US
and abroad; and corrupted the governments of Mexico and our
neighbors south of the border. Rather than deter the flow of illicit
drugs in to the US, it has grown exponentially. Marijuana, cocaine,
and heroine are now not only more potent, but also more readily
accessible to addicts. With regard to prescription painkillers the
true culprits are the direct diversion of large amounts of drugs
from the licensed manufacturers by truck hi-jackings, warehouse
robberies, and white collar crime. You can add to this list drugs
diverted from veterinary use by vets assistants and other
intermediaries; unscrupulous physicians writing thousands of RX's
for a living who are themselves addicts; and pills diverted from
pharmacies by robberies, white collar crime, and chemically
dependent pharmacists. The licensed manufacturers have also
admitted to the federal government that they profit from
manufacturing more drugs than are warranted by the normal laws of
legitimate supply and demand, yet they have not been forced to cut
back. The FDA has no business micromanaging the medical care of
legitimate pain patients through constant UDA's, databases, and
other methods that conflict with a patient's right to privacy; or to
scrutinize the physicians that treat them to the point where they
are unwilling to provide adequate analgesic relief for patients,
because they live in fear of legal sanctions despite practicing in
an ethical manner. This over regulated legitimate activity
contributes almost nothing to the overall supply of illicit drugs in
the US. I might also point out again that despite high profile cases
like Michael Jackson, Rush Limbaugh, and bereaved parents, the
actual risk of addiction to pain meds in adult chronic pain patients
is known to be very low. Limbaugh and Jackson were being treated for
short term medical conditions and also had the financial means to
easily avail themselves of unscrupulous doctors..

This survey is a poll of those who choose to participate and are, therefore, not valid statistical samples, but rather a snapshot of what your colleagues are thinking.

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